Theraflu Severe Cold Relief Daytime Berry Burst

Description

HALEON's THERAFLU MULTI-SYMPTOM COLD RELIEF is a daytime formula designed to alleviate severe cold symptoms. Each packet contains a combination of active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This formulation provides hot liquid therapy that effectively relieves nasal and sinus congestion, cough, sore throat pain, headache, and fever. The product is available in a berry burst flavor and is packaged in a box containing six individual packets. The National Drug Code (NDC) for this product is 0067-6800-02.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, minor sore throat pain, headache, nasal and sinus congestion, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take one packet. For children under 12 years of age, the product is not recommended.

The administration of the medication should occur every 4 hours while symptoms persist. Patients must not exceed 5 packets within a 24-hour period unless specifically directed by a healthcare professional.

To prepare the medication, the contents of one packet should be dissolved in 8 ounces of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If utilizing a microwave for preparation, the contents of one packet should be added to 8 ounces of cool water. It is important to stir the mixture briskly both before and after heating. Care should be taken to avoid overheating the solution.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 12 years of age.

• In individuals with a known allergy to acetaminophen.

• In conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms arise, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician without delay.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Discontinuation of Use Patients should be advised to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms develop; or if pain, cough, or nasal congestion worsens or lasts more than seven days. Additionally, if a cough recurs or is accompanied by a rash or headache that persists, medical evaluation is warranted, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if pain, cough, or nasal congestion worsens or lasts more than seven days. A return of cough accompanied by rash or headache that persists should also prompt medical evaluation.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a healthcare professional. Those with a cough that produces excessive phlegm or a chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric, or emotional conditions, or for Parkinson’s disease. This contraindication extends for a period of two weeks following the discontinuation of the MAOI.

Caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Monitoring of coagulation parameters may be necessary to ensure therapeutic efficacy and safety.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu Severe Cold Relief Daytime Berry Burst (acetaminophen, dextromethorphan hbr, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. For those aged 12 years and older, the recommended dosage is one packet. Safety and efficacy have not been established in children younger than 12, and therefore, use in this population is contraindicated.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20 to 25°C (68 to 77°F). It is essential to protect the product from heat and moisture to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Theraflu Severe Cold Relief Daytime Berry Burst, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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